The Food Additives Amendment of 1958 is a 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938. It was a response to concerns about the safety of new food additives. The amendment established an exemption from the "food additive" definition and requirements for substances "generally recognized as safe" by scientific experts in the field, based on long history of used before 1958 or based on scientific studies. New food additives would be subject to testing including by the "Delaney clause". The Delaney clause was a provision in the amendment which said that if a substance were found to cause cancer in man or animal, then it could not be used as a food additive.

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Generally recognized as safe (GRAS) is a Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.[1] The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958, and all additives introduced after this time had to be evaluated by new standards.

The Delaney Clause is a provision in the amendment named after Congressman James Delaney of New York. It said:

"the Secretary of the Food and Drug Administration shall not approve for use in food any chemical additive found to induce cancer in man, or, after tests, found to induce cancer in animals."[2]

The Delaney Clause applied to pesticides in processed foods, but only when the concentration of a residue of a cancer-causing pesticide increased during processing; for example when more of a pesticide was present in ketchup than in the raw tomatoes used to make it. (It never applied to pesticides in raw foods.) When the law was passed, "neither advocates nor opponents of the policy, including FDA ofﬁcials, believed it would have broad application, for only a handful of chemicals had then been shown to be animal carcinogens."[2]

The Delaney Clause was invoked in 1959 when Arthur Sherwood Flemming, the Secretary of the Department of Health, Education and Welfare issued a statement advising the public about the possible contamination of substantial quantities of cranberries in Oregon and Washington with the herbicideaminotriazole, which the FDA had recently determined was a carcinogen (see Cranberry scare of 1959). Taking place the week of Thanksgiving, the announcement was referred to by many in the cranberry industry as "Black Monday" − sales plummeted, even though many government officials attempted to defuse the scare by declaring their intention to eat cranberries anyway. This episode is regarded as one of the first modern food scares based on a chemical additive.

As analytical chemistry became more powerful and able to detect smaller quantities of chemicals, and as chemicals became more widely used, regulatory agencies had an increasingly difficult time administering the Delaney Clause as it "recognizes no distinctions based on carcinogenic potency and, at least in theory, it applies equally to additives used in large amounts and to those present at barely detectable levels. It thus takes no account of the actual risk a carcinogenic additive might pose."[2]

The FDA was the first agency to have to confront this problem, with respect to the use of diethylstilbestrol to promote the growth of livestock used in meat production, which remained present in the meat. It addressed the issue by using quantitative risk assessment, declaring that if a carcinogenic food additive was present at a concentration of less than 1 part in 1,000,000, the risk was negligible. This standard became known as the "de minimis" exception to the Delaney Rule and was used throughout the FDA and other agencies.[2]

The Delaney prohibition appears in three separate parts of the FDCA: Section 409 on food additives; Section 512, relating to animal drugs in meat and poultry; and Section 721 on color additives. The Section 409 prohibition applied to many pesticide residues until enactment of the Food Quality Protection Act of 1996. This legislation removed pesticide residue tolerances from Delaney Clause constraints.

Many foods contain natural substances which are carcinogenic, for example safrole, which occurs in sassafras and sweet basil. Even these substances are covered by the Delaney clause, so that, for example, safrole may not be added to root beer in the USA.[3]